Gentuzumab Ozogamicin and Midostaurin Combination With Standard Cytarabine and Danunorubi Midostaurin as a Novel Approach to Treating Patients With Newly Diagnosed FLT-3 Mutated Acute Myeloid Leukemia

Summary

This phase I study hopes to explore how safe and tolerable is the combination of gemtuzumab ozogamicin (GO) and midostaurin, with the standard induction therapy (cytarabine and daunorubicin) in patients with newly diagnosed FLT-3 mutated Acute Myeloid Leukemia (AML). GO is FDA approved for the treatment of adults with newly diagnosed CD33 positive AML and used in combination with chemotherapy, cytarabine and daunorubicin. Midostaurin is FDA approved for use with cytarabine and daunorubicin in patients with FLT3-mutated AML. By combining standard induction therapy with GO and midostaurin, our aim is to investigate a novel approach to treating patients with newly diagnosed FLT3-mutated AML.

Timeline

Start

2019-03-13

Primary completion

2024-08-08

Completion

2025-10-23

Publications

• Jain J, Pugh K, Handa S, Dvorak-Kornaus KM, Zhao Q, Walter RB, Cook R, Saultz J, Swords R, Li J, Laszlo GS, Grieselhuber NR, Mims AS, Larkin KTM, Sahasrabudhe K, Blachly JS, Behbehani GK, Eisfeld AK, Long M, Srisuwananukorn A, Koenig KL, Borate U. Safety of gemtuzumab ozogamicin with cytarabine, daunorubicin, and midostaurin induction in FLT3-mutated AML. Blood Neoplasia. 2025 Oct 9;3(1):100171. doi: 10.1016/j.bneo.2025.100171. eCollection 2026 Feb.

Drugs

Indications